Dicerna Pharmaceuticals Inc. (Dicerna) is committed to creating a climate and culture that promotes objectivity in research by establishing standards that help ensure that the design, conduct and reporting of Public Health Service (PHS, which includes National Institutes of Health or NIH) funded research is free from bias resulting from financial conflict of interest (FCOI).
The Dicerna FCOI policy consists of:
Dicerna is committed to creating a climate and culture that promotes objectivity in research by establishing standards that help ensure that the design, conduct and reporting of PHS, which includes NIH funded research is free from bias resulting from financial conflict of interest (FCOI)
This policy applies to each Dicerna employee who is planning to or is participating in research activity that is either partially or wholly supported by PHS funds. This policy is in addition to Dicerna’s Code of Business Conduct and Ethics (the Code of Conduct) that governs Dicerna’s business decisions and actions throughout the world and applies equally to corporate actions and to the behavior of individual employees when conducting Dicerna’s business. If there is a conflict between this policy and the Code of Conduct, the Code of Conduct will govern. Every Dicerna employee must:
- Disclose his or her significant financial interests (SFI) in non-Dicerna entities that would appear to be related to the employee’s professional responsibilities on behalf of Dicerna;
- Comply with a FCOI management plan, if a FCOI is identified; and
- Undergo FCOI training, at least once every four years.
Disclosure of SFI is essential for Dicerna to determine if a FCOI exists, and in cases of FCOI determine how it will be managed and reported in full compliance with government regulation. Non-disclosure of SFI or non-compliance with FCOI management plan may subject the employee to disciplinary action up to and including suspension or termination of employment.
- Financial conflict of interest (FCOI) means a significant financial interest in a non-Dicerna entity that either does or appears to be related to the employee’s professional responsibilities on behalf of Dicerna that could directly and significantly affect the design, conduct, or reporting of PHS funded research.
- Significant Financial Interest (SFI) exists if the value of remuneration received by the employee, employee’s spouse or dependent children from a non-Dicerna entity that reasonably appear to be related to the employee’s Dicerna PHS grant responsibilities exceeds $5000;
- Salary or other payments for services (e.g., consulting fees or honoraria) received in the twelve months preceding disclosure;
- Equity interests (e.g., stocks, stock options or other ownership interests)l however, equity interest in a non-publicly traded entity, no matter the amount, constitutes an SFI; and,
- Income from intellectual property rights owned by the employee.
- Salary, royalties, stock options or other remuneration from Dicerna;
- Income from seminars, lectures, teaching engagements, service on advisory committees or review panels, derived from excluded sources;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the employee does not directly control the investment decisions; and,
- Unlicensed intellectual property owned by the employee that does not generate income. Note that Intellectual property owned by Dicerna is excluded.
SFI disclosure also includes travel. Specifically, externally funded, reimbursed or sponsored travel provided by a non-Dicerna entity that either is or appears to be related to the employee’s Dicerna PHS grant responsibilities would need to be disclosed as a potential FCOI. Such travel must be disclosed, no matter the amount, except when the expenses are covered by any of the excluded sources.
*Note that the threshold of $5000 is applied to the aggregation of 1 and 2, or to 3.
- Employee’s professional responsibilities on behalf of Dicerna means conducting research, submitting patent applications, publication, technical committee membership and, teaching as adjunct faculty at an Institute of higher education.
- An excluded source means a source of remuneration that is excluded from disclosure. With reference to remuneration that is excluded from FCOI consideration in Sections 2b and 3 above, excluded sources are – federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
Employees who are planning to or participating in research activity that is either partially or wholly supported by PHS funds must disclose their SFI in a timely fashion, either to the Chief Compliance Officer or the Chief Ethics Officer designated under the Code of Conduct. The Chief Compliance Officer or the Chief Ethics Officer will determine whether the SFI constitutes an FCOI, based on this policy and the PHS FCOI rules. Consistent with the attached Protocol for Handling Financial Conflict of Interest, if the SFI is determined to be an FCOI, the Chief Compliance Officer or the Chief Ethics Officer will take actions to discuss and approve the implementation of an FCOI management plan consistent with government regulation and, furthermore, to promptly notify the PHS funding component (e.g., NIH) via a FCOI report.
As a part of the FCOI management plan, the Chief Compliance Officer or the Chief Ethics Officer will decide one or more actions depending upon the situation, including requiring certain disclosure in public presentations, employee role reassignment, reduction or elimination of the financial interest sanctions (e.g., sale of an equity interest) or severance of relationships that create financial conflicts. Employees with an identified FCOI must comply with the FCOI management plan.
The Chief Compliance Officer and the Chief Ethics Officer are responsible for administration of this policy.
Protocol for the Administration of FCOI
This protocol along with the policy and procedure titled, Financial Conflict of Interest in PHS-Funded Projects, constitute the Dicerna FCOI policy. Capital terms in this protocol shall have the same meaning as set forth in the policy. This protocol outlines the procedure that will be followed as per regulation (Title 42 CFR 50.601-50.607).
This document specifies the FCOI protocol for PHS-funded research: that is the step-by-step implementation of the PRNA FCOI policy.
Who is required to disclose financial interests
Employees planning to or participating in research activity that is either partially or wholly supported by PHS funds are required to disclose financial interests (“PHS-funded Investigators”).
Dicerna employees participating in PHS-funded research are required to disclose SFIs to either the Chief Compliance Officer or Chief Ethics Officer at Dicerna as follows:
- Employees planning to participate in PHS-funded research are required to disclose all SFI’s prior to submission of an application for PHS-funded research.
- Once the research project has been funded all Dicerna employees participating in PHS-funded research shall submit SFI Disclosures within thirty (30) days of acquiring any new or increased SFI,
- When a new employee joins an ongoing PHS-funded project, the employee shall submit SFI disclosures within thirty (30) days of joining the project.
- All Dicerna employees participating in PHS-funded research shall submit an updated SFI disclosure annually.
- SFI disclosures (except travel) must include the following information:
- Identity of the sponsor/organizer; and
- Nature of SFI (e.g., salary, license income, stock).
- Externally funded travel also constitutes SFI, and therefore the disclosure requirements in 2 (i)-(iii) apply. That is, PHS-funded investigators shall submit SFI Disclosures for externally funded travel: prior to submission of an application for PHS-funded research; and for PHS-funded projects within thirty (30) days of externally funded travel and in an annual update. The following travel related information must be disclosed:
- Identity of the sponsor/organizer,
- Destination, and,
Review of disclosures
All SFI disclosures, including those submitted by a new Dicerna employee who joins an ongoing PHS-funded project, will be reviewed by the designated Dicerna FCOI official. The review will determine whether an SFI is related to the PHS-funded research and therefore whether a FCOI exists. The Chief Compliance Officer and Chief Ethics Officer may involve the relevant Dicerna employee in the FCOI review and request additional information from the employee as necessary to make a determination.
When an SFI that was not disclosed by a PHS-funded Investigator in a timely manner is identified, the Chief Compliance Officer or Chief Ethics Officer will determine if a FCOI exists, develop and implement a management plan within sixty (60) days after the identification of the SFI. In addition, the Chief Compliance Officer or Chief Ethics Officer will conduct a retrospective review of SFIs for the PHS-funded investigator within one hundred twenty (120) days and document it.
Management of FCOI
For each disclosure that leads to determination of FCOI, the Chief Compliance Officer and the Chief Ethics Officer will discuss and approve the implementation of a management plan developed to manage the FCOI. Dicerna employees participating in PHS-funded research and who have an identified FCOI must comply with the management plan. The management plan will include the following elements at a minimum:
- The role and principal duties of the conflicted employee participating in the PHS-funded research project;
- Conditions of the management plan (see examples below);
- How the management plan is designed to safeguard objectivity in the research project;
- Confirmation of the employee’s agreement to the management plan; and
- How the management plan will be monitored to ensure the employee’s compliance.
Examples of conditions or restrictions that might be imposed to manage a Dicerna employee’s FCOI include, but are not limited to:
- Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research; to staff members working on the project; to Institution’s Institutional Review Board(s));
- For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;
- Reduction or elimination of the financial interest (e.g., sale of an equity interest) to bring within the threshold identified above; or
- Severance of relationships that create financial conflicts.
Reporting FCOI to PHS Awarding Component (e.g. the NIH)
Based on the FCOI management plan, the designated Dicerna FCOI official will submit an initial FCOI report to the PHS-funding component, for example NIH. The report will be submitted, for example using eRA Commons for NIH, and consist of all elements required by the regulation.
The FCOI report must be submitted prior to the expenditure of funds under the Notice of Award. FCOIs identified during the period of award will be submitted to NIH within sixty (60) days of identification, including for new Dicerna employees joining an ongoing PHS-funded project.
Annual FCOI reports (or revised reports as a result of retrospective reviews) will also be submitted and will include the status of financial conflict, i.e., whether the financial conflict is still being managed or explains why the financial conflict no longer exists. These FCOI reports will also include a description of any changes to the management plan since the last FCOI report.
Training for FCOI
PHS-funded Investigators must undergo training with respect to this Policy and PHS FCOI rules and regulations, as follows:
- When a new employee joins PRNA;
- Prior to participating in PHS-funded research, and at least once every four years;
- When the PRNA FCOI policy changes in a manner that impacts the disclosure or compliance requirements of Dicerna employees participating in the PHS-funded research; and,
- If PRNA MT determines that a Dicerna employee participating in PHS-funded research is not compliant with the FCOI Policy or an FCOI Management Plan.
NIH web-based training (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm) will be used. Employees must save and print the FCOI Certificate as proof of completion.
Sanctions for violation of policy
Disclosure of SFI is essential for Dicerna to implement its FCOI policy. If a Dicerna employee participating in PHS-funded research fails to comply with this policy (with regard for instance to the SFI disclosure requirement or implementation of an FCOI management plan), and appears to have biased the PHS-funded research, the Chief Compliance Officer and the Chief Ethics Officer will implement a mitigation plan and require that the employee disclose the FCOI in each public presentation of the results of the research, and to remedy previously published presentations with an FCOI disclosure addendum. In addition, the employee may be subject to employment discipline including, without limitation, suspension or termination of employment.
In any case, the PHS-funding agency will be promptly notified.
Retention of records
Records of financial disclosures and any resulting action will be maintained for three (3) years from the date of submission of the final expenditures report.
When working with a subrecipient, a written agreement will be put in place to clarify: (a) which organization’s (prime awardee or subrecipient) FCOI policy will be followed, and, (b) in either case, clarify the timeline for disclosure and reporting. Note that the prime awardee is responsible for monitoring subrecipient’ s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest.
As required by PHS regulation, this policy is being made accessible on Dicerna web site.
If a Dicerna employee participating in PHS-funded research holds financial interests that are determined to be FCOI, as required by PHS regulation, these will also be posted on the web site, as follows:
- Include the minimum elements required by the regulation;
- Update within sixty (60) days of a newly identified FCOI;
- Update annually; and
- Remain available for three (3) years.